Stories
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Technology Leaders: Regulations/Standards
Modern evaluation of biocompatibility uses a risk-based approach.
Features: Regulations/Standards
Bring your project from the process development phase of manufacturing to a fully validated one.
From the Editor: Regulations/Standards
New best practices for understanding medical device security.
Supplements: Mechanical & Fluid Systems
In our winter edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
Features: Manufacturing & Prototyping
A robust, optimized mechanical testing program is essential to successful quality control testing.
Products: Tubing & Extrusion
Linear stepper stages, tubing, Bluetooth modules, and more.
Supplements: AR/AI
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
From the Editor: Medical
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
Features: Transportation
The "Evolving To MedDev" 2021 digital event will provide automotive and aerospace companies with practical information about how they can enter into the medical device supply chain.
Features: Regulations/Standards
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
From the Editor: Regulations/Standards
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Briefs: Regulations/Standards
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Products: Software
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
Features: Regulations/Standards
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
From the Editor: Software
FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production of...
Features: Test & Measurement
How to make sense of the 566-page Medical Device Regulation (MDR). This article focuses on a strategy to address material information and what should be included in a gap analysis.
Features: Medical
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.
Briefs: Medical
In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...
Features: Manufacturing & Prototyping
Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...
Briefs: Regulations/Standards
Ovarian cancer is usually diagnosed only after it has reached an advanced stage, with many tumors spread throughout the abdomen. Most patients undergo surgery to remove as many of these...
Features: Regulations/Standards
The Luer connector is arguably one of the most important developments in the biomedical industry. Because it is reliable, simple to use, and economical to produce, the Luer connector...
News: Regulations/Standards
As of September 2018, Instron’s Calibration Laboratory in Norwood, MA USA (NVLAP Lab Code 200301-0) expanded its global reach to include Europe into its existing operations. This addition...
Features: Test & Measurement
Meeting the requirements for patient-connected medical devices can present challenges for power system designers. There are several key elements to consider, including isolation,...
Features: Medical
The fourth edition IEC/EN 60601-1-2 (4th Edition) will become a mandatory standard covering safety for medical devices on December 31, 2018.1,2 As with any new standard edition, there are...
Features: Medical
When validating the steam sterilization instructions for a reusable medical device,...
INSIDER: Manufacturing & Prototyping
A grant from the National Institute of Standards and Technology (NIST) will be used to to develop standards for regenerative medicine and biomaterial manufacturing. NIST awarded...
Features: Regulations/Standards
A key driver of the medical disposables market is the desire to minimize the risk of healthcare-associated infections (HAIs). Healthcare providers are turning to disposable products...
News: Test & Measurement
Medical Device Preclinical Bootcamp to Explore Testing Pathway
An upcoming seminar will explore the preclinical testing pathway for medical devices. The event will cover everything from concept to regulatory submission, including relevant regulations and standards, as well as the role each type of test plays in the overall testing program. It will...
Features: Regulations/Standards
In an industry where people's health and wellness are on the line, manufacturers can't afford to let risk go unaddressed. As the International Organization for Standardization...
Top Stories
INSIDER: Sensors/Data Acquisition
Tiny Sensor Could Transform Head Injury Detection
News: Medical
Quantum Surgical Acquires NeuWave Medical, Inc.
Briefs: Manufacturing & Prototyping
Shrinking Materials Hold Big Potential for Smart Devices
Podcasts: Medical
Surgical & Assistive Robotics: Redefining Human Capability
INSIDER: Software
MD&M West Presentation: How Intelligent Product Lifecycle Management...
Products: Materials
Ask the Expert
Eric Dietsch on the Benefits of Nitinol Wire
In collaboration with the Fort Wayne Metals Engineering team, Eric Dietsch focuses on supporting customers with material recommendations, product development, and education. Eric is available to help you and your company with any Nitinol-related questions or needs that you may have.
Webcasts
Podcasts: Robotics, Automation & Control
The Hidden Nervous System of Surgical Robotics: Power, Data & Sensing Behind...
Podcasts: Robotics, Automation & Control
Surgical & Assistive Robotics: Redefining Human Capability
Podcasts: Medical
How Wearables Are Enhancing Smart Drug Delivery
Podcasts: Design
Developing Sustainable Drug-Delivery Devices
Podcasts: Design
Smarter Pathways for Precision Drug Delivery in Cancer Care
On-Demand Webinars: Manufacturing & Prototyping
Understanding Testing and Compliance Requirements for Wireless Medical Devices
Inside Story
Inside Story: Trends in Packaging and Sterilization
Eurofins Medical Device Testing (MDT) provides a full scope of testing services. In this interview, Eurofins’ experts, Sunny Modi, PhD, Director of Package Testing; and Elizabeth Sydnor, Director of Microbiology; answer common questions on medical device packaging and sterilization.
